Exclusive Distribution Agreement Medical Device

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(b) Without falling under Section 7.4(a), Given Imaging has the exclusive and exclusive ownership of all results and information relating to the performance of this Agreement by either party, if (i) suzuken suzuken uses confidential information (as defined below) of Given Japan or Given Imaging or with the participation of employees of Given Japan or Given Imaging or the performance of their obligations under of this Agreement and (ii) relates to the Product, including, but not limited to, all copyrights and marketing information and materials. (u) cooperate in a timely manner with Given Japan on all medical vigilance matters and report any product problems; CONSIDERING that CONOR BIOTRONIK wishes to supply Unistar and Costar stents and other products (together and in particular, as defined below, the products) and appoint BIOTRONIK as exclusive distributor in the area indicated in Appendix B. “Non-sales targets” allow you to measure your distributor`s performance in the absence of concrete sales figures. For example, if you need the buy-in of certain Key Opinion Leaders (KOLs), be sure to quantify the required number of KOL meetings per month in the contract. If your distributor doesn`t have access to these meetings, you know you won`t be making sales in the future and it`s best to find a new distributor sooner rather than later. Other examples of non-sale targets are: 1.3 Restrictions. Such appointment, in accordance with section 1.1, shall be governed by all applicable laws and directives in the Territory. Suzuken may not use the Product for any purpose other than those of this Agreement without the express, prior written permission of Given Japan, and Suzuken may not sell, market or market the Product or conduct marketing activities regarding the Product outside the Territory. Under this Agreement, Suzuken has no distribution rights for Given Imaging products other than the Product. Suzuken will not market the product as such in combination with other products or technologies or as a product in its own right and will not attempt to separate the components from the product or use any component separately and not as part of the product, without the prior written consent of Japan. This Agreement shall apply from 25 11.4 Termination by Given Japan of 11 May 2004 (date of entry into force).

Japan may, at its discretion, terminate (or not make exclusive the distribution rights) upon prior written notice (unless a shorter period of time is indicated below); if: (i) [***Redacted**]; or (ii) [****Redacted**]; or (iii) [****Redacted**] or (iii) after [*Redacted*] prior notification if [**Redacted***] BIOTRONIK has the following obligations with regard to the marketing and distribution of products: 17.2 Publication, press releases. Both parties may issue press releases relating to the existence of an agreement between the parties, without disclosing the commercial details of the agreement and subject to their respective confidentiality obligations. Both Parties shall provide the other Party with a copy of a draft press release relating to the other Party for prior approval prior to its publication. Authorisations shall not be inappropriately refused and must be issued in good time. 17.9 Comprehensive Agreement. This Agreement, including all additions and annexes, constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and supersedes all prior agreements, understandings or assurances, either orally or in writing, between the Parties with respect to this matter. CONOR has established and maintains a quality management system in accordance with ISO 13485 and other relevant quality management standards and regulations, such as Council Directive 93/42/EEC of 14 June 1993 on medical devices. CONOR ensures and guarantees that the actual production of the product will be done under the certified quality management system. . . .

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